EMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) to inform and help healthcare professionals answer questions about the evaluation, approval and monitoring of safe, effective and high-quality COVID-19 vaccines.

‘Healthcare professionals are the heroes of this pandemic,’ said Emer Cooke, Chair of ICMRA and EMA’s Executive Director. ‘We are aware that many citizens want more information about the development, regulatory review and safety monitoring of COVID-19 vaccines and they will ask their doctors or nurses. ICMRA has developed this statement to support healthcare professionals when talking to members of the general public to reassure them that the regulatory processes for the authorisation and safety monitoring of COVID-19 vaccines are robust, independent and driven by patient and public health needs.’

In their joint statement, international regulators explain how COVID-19 vaccines undergo scientific evaluation to determine their safety, efficacy and quality. They also reiterate that regulators continue to rigorously monitor the safety of vaccines after approval for use. ICMRA members emphasise that regulators, in collaboration with public health authorities, are able to take decisive action if and when a safety issue is identified.

The development of the ICMRA statement followed a series of meetings and discussions among international regulators from around the world on new ways to enhance public confidence in vaccines against COVID-19.

Posted on the EMA website on 19 January 2021